Endo Endoengineering Srl
Risk Analysis Service
During a product, machine, electronic or medical devices, design the manufacturer must always be sure he has created a device that reach the expected performance and also is safe for users and staff involved in use or maintenance. A systematic approach to assessing the safety aspects of a product can be obtained by implementing engineering methodologies of risk assessment, which allow you to analyze and identify the causes and potential risks related to an event and the technological and organizational solutions to reduce the impact.
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Some European directives oblige the manufacturer to develop a risk analysis before certifying the product, some of these directives are the Machinery Directive, the Medical Device Directive, the Pressure Equipment Directive PED, ATEX Directive on potentially explosive atmospheres.
There are several methodologies for the development of a risk management plan, for example:
- FMEA (Failure Mode and Effects Analysis)
- FTA (Falut Tree Analysis)
- HAZOP (Hazard and operability Study)
- HACCP Hazard Analysis and Critical Control Point
Risk analysis is the cornerstone of every product and technical documentation and rapresents the tool that designers and builders have to create a device that is safe for the user or the operator. Making a good risk analysis requires experience and professionalism that the engineers of Endo and Engineering have put at your disposal.